Friday, March 25, 2005

Health Group Claims FDA Performance Standards Would Make Cigarettes Less Harmful

In a web site report that was shared with individual tobacco control advocates this week, the Campaign for Tobacco-Free Kids argues that FDA performance standards proposed in the FDA tobacco legislation re-introduced in Congress last Thursday would make cigarettes less harmful. These performance standards refer to authority that would be given to FDA to require tobacco manufacturers to reduce or eliminate certain tobacco product ingredients or smoke constituents. The report went on to explain that these performance standards are in fact the primary way by which this legislation would make tobacco products less harmful.

According to the report: "These bills provide FDA with the authority to require changes to tobacco products to protect the public health, such as the reduction or elimination of ingredients, additives, and constituents, including smoke constituents ... A performance standard would be the primary way in which FDA would require tobacco products to be made less harmful."

The Rest of the Story

While on first impression, these performance standards might sound like a reasonable idea, closer inspection reveals that the idea is actually quite absurd. If tobacco smoke contained one or perhaps a few carcinogens, then it would make sense to attempt to regulate the safety of the product by setting standards for the presence of, or levels of, these carcinogens. But with over 40 known carcinogens, what sense is there in proposing to regulate the safety of the product by setting performance standards that would eliminate or reduce levels of just a number of these carcinogens? And what evidence is there to support an assertion that getting rid of a few of these carcinogens would make any significant difference in reducing the overall harm of the product?

Unfortunately, we simply do not know which specific carcinogens of the 40+ carcinogens in tobacco smoke and which specific toxins of the 4000+ chemicals in tobacco smoke are responsible for what diseases, what quantities of these chemicals produce what effect, and what the effect of removing these chemicals will be, as well as how the combination of chemicals removed will affect disease risk, if at all, and whether the processes used to alter the chemical makeup of cigarette smoke will introduce new chemicals that may even be more hazardous to health. There is absolutely no evidence to support a contention that requiring removal of a few selected substances in tobacco products would substantially reduce the health risks of smoking. Thus, any claim of public health relevance of such a requirement is completely unsubstantiated.

Consider the following list of carcinogens in tobacco smoke (from the 1989 Surgeon General's report): Benz(a)anthracene, Benzo(b)fluoranthene, Benzo(j)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Chrysene, Dibenz(a,h)anthracene, Dibenzo(a,i)pyrene, Dibenzo(a,l)pyrene, Indeno(1,2,3-c,d)pyrene, S-Methylchrysene, Quinoline, Dibenz(a,h)acridine, Dibenz(a,j)acridine, 7H-Dibenzo(c,g)carbazole, N-Nitrosodimethylamine, N-Nitrosoethylmethylamine, N-Nitrosodiethylamine, N-Nitrosopytrolidine, N-Nitrosodiethanolamine, N’-Nitrosonomicotine, 4-(Methylnitrosamino)- 1-(3-pyridyl)-1-butanone, N’-Nitrosoanabasine, N-Nitrosomorpholine, 2-Toluidine, 2-Naphthylamine, 4-Aminobiphenyl, Formaldehyde, Acetaldehyde, Crotonaldehyde, Benzene, Acrylonitrile, 1, 1 -Dimethylhydrazine, 2,Nitropropane, Ethylcarbamate, Vinyl chloride, Hydrazine, Arsenic, Nickel, Chromium, Cadmium, Lead, Polonium-210.

If FDA decided to require the elimination of 10 of these carcinogens (which is an optimistic assumption given the nature of the regulatory process), and the resulting list of carcinogens in cigarettes was as follows, would the product be substantially safer to smoke? Benz(a)anthracene, Benzo(b)fluoranthene, Benzo(j)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Chrysene, Dibenz(a,h)anthracene, Dibenzo(a,i)pyrene, Dibenzo(a,l)pyrene, Indeno(1,2,3-c,d)pyrene, S-Methylchrysene, Quinoline, Dibenz(a,h)acridine, Dibenz(a,j)acridine, 7H-Dibenzo(c,g)carbazole,, N-Nitrosoethylmethylamine, N-Nitrosodiethylamine, N’-Nitrosoanabasine, N-Nitrosomorpholine, 2-Toluidine, 2-Naphthylamine, 4-Aminobiphenyl, Formaldehyde, Acetaldehyde, Crotonaldehyde, Benzene, Acrylonitrile, 1, 1 -Dimethylhydrazine, 2,Nitropropane, Ethylcarbamate, Vinyl chloride, Hydrazine, Arsenic.

It should be clear how absurd this strategy for regulating the safety of cigarettes is from a public health perspective. To me, it seems misleading for public health groups to give the public the perception that performance standards will somehow make cigarettes a safer product. After all, these same public health groups are protesting the use of words like "mild" and "light" by cigarette companies, claiming that smokers are being misled into thinking that such cigarettes are safer. If public health practitioners are truly concerned about the adverse impact of unsubstantiated health claims, then they should certainly not be making any health claims that they cannot substantiate themselves. And the claim that performance standards "are in fact the primary way by which this legislation would make tobacco products less harmful" seems to me to be misleading, based on the above analysis.

Along similar lines, the health groups are touting that the legislation's requirement that cigarette companies disclose the complete list of ingredients, additives, and constituents in tobacco smoke would be an important public health victory. Given the complex nature of tobacco smoke, I doubt that such a requirement could be met, short of years and years of laboratory work. Nevertheless, even if it could be met, it has no relation whatsoever to the health of the public. What else do we need to know beyond the fact that cigarettes are deadly? Having a complete list of the thousands (and according to the National Cancer Institute, there may be hundreds of thousands) of smoke constituents is not going to help make tobacco products safer.

It seems to me that the effort to try to regulate the safety of tobacco products through an ingredient-by-ingredient approach is absurd, senseless, and a complete waste of resources. We simply cannot regulate the safety of this particular product, and we should not try to do so. Shouldn't we be concentrating our efforts on trying to get people to quit smoking and preventing them from starting to smoke, rather then pretending that the Food and Drug Administration will, in its infinite wisdom, be able to give companies a list and magically produce a safer cigarette?

I certainly hope that there are enough sensible public health advocates out there who realize how absurd this FDA tobacco legislation is. It would be a disaster for public health, and more specifically - a disaster for smokers, who would be grossly misled by the impression that the product is going to become safer, if this legislation were to be enacted.

1 comment:

Anonymous said...

What about the known prevalence of the listed tobacco smoke carcinogens,in other areas.Such as food processing,building products and so on?